Golfyeti,

I'm not sure if BETonMACE trial would be able to support an NDA/MMA filing for renal or Alzheimers. The only listed primary outcome measure is the time to 3-point MACE. All the other listed outcomes are secondary outcomes (for the whole list check out the ClinicalTrials.gov page). Any posters here familiar with this process that can add some clarity? I found a good description on pages 9-11 about the distinction of primary and secondary endpoints in this 2017 draft FDA document.

BDAZ